Trial Outcomes & Findings for Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia (NCT NCT04757805)

NCT ID: NCT04757805

Last Updated: 2023-01-26

Results Overview

The vertebral interspace that the anesthesia provider believes that they had marked \& identified by manual palpation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Immediately prior to spinal anesthesia
• Results posted on: 2023-01-26

Participant Flow

Participant milestones

Measure	Spinal Anesthesia Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Spinal Anesthesia n=50 Participants Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
Age, Categorical <=18 years	50 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=50 Participants
Age, Continuous	7 months n=50 Participants
Sex: Female, Male Female	0 Participants n=50 Participants
Sex: Female, Male Male	50 Participants n=50 Participants
Region of Enrollment United States	50 participants n=50 Participants
Height	66.5 centimeters n=50 Participants
Weight	7.8 kilograms n=50 Participants
American Society of Anesthesiologists (ASA) status ASA I	29 Participants n=50 Participants
American Society of Anesthesiologists (ASA) status ASA II	18 Participants n=50 Participants
American Society of Anesthesiologists (ASA) status ASA III	3 Participants n=50 Participants

PRIMARY outcome

Timeframe: Immediately prior to spinal anesthesia

The vertebral interspace that the anesthesia provider believes that they had marked & identified by manual palpation

Outcome measures

Measure	Spinal Anesthesia n=50 Participants Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
Intended Interspace L2-3	1 Participants
Intended Interspace L3-4	24 Participants
Intended Interspace L4-5	25 Participants

PRIMARY outcome

Timeframe: Immediately prior to spinal anesthesia

The actual vertebral interspace that the anesthesia provider marked & identified, as verified by ultrasound.

Outcome measures

Measure	Spinal Anesthesia n=50 Participants Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
Actual Interspace of Provider's Mark L2-3	5 Participants
Actual Interspace of Provider's Mark L3-4	24 Participants
Actual Interspace of Provider's Mark L4-5	21 Participants

SECONDARY outcome

Timeframe: Immediately prior to spinal anesthesia

Assessing the level of the conus medullaris by ultrasound in the sitting position.

Outcome measures

Measure	Spinal Anesthesia n=50 Participants Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
Level of Conus Medullaris - Sitting Unable to obtain	2 Participants
Level of Conus Medullaris - Sitting T12-L1	9 Participants
Level of Conus Medullaris - Sitting L1-2	27 Participants
Level of Conus Medullaris - Sitting L2-3	9 Participants
Level of Conus Medullaris - Sitting L3-4	3 Participants

SECONDARY outcome

Timeframe: Immediately prior to spinal anesthesia

The amount of time if took for the anesthesia provider to manually palpate and mark the desired interspace.

Outcome measures

Measure	Spinal Anesthesia n=50 Participants Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
Time to Mark	25 seconds Interval 14.3 to 32.0

SECONDARY outcome

Timeframe: Immediately prior to spinal anesthesia

The amount of time it took for the investigator to identify the actual space that the provider marked using ultrasound.

Outcome measures

Measure	Spinal Anesthesia n=50 Participants Infants receiving spinal anesthesia for standard of care procedure Ultrasound: Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
Time to Conduct Ultrasound	38.5 seconds Interval 29.0 to 63.8

Adverse Events

Spinal Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Giorgio Veneziano, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: Giorgio.Veneziano@nationwidechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place